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Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting

NCT06229639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-11

Study results available
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Summary

Limited research has been done to assess the safety of PMV use during sleep. One prospective study completed by Diez-Gross, et al in 2007 looked at 10 male subjects recorded on two consecutive nights, one night with PMV on and one night with PMV off. All recordings took place in a monitored setting. The variables studied included O2 saturation, apnea index, apnea - hypopnea index, and nursing reports. Conclusion was PMV use for one night in seriously ill tracheostomy patients was not associated with respiratory distress or cardiac issues.

Conditions

  • Tracheostomy

Interventions

DEVICE

Passy Muir Valve

DEVICE

Tracheostomy Plug

Sponsors & Collaborators

  • Gaylord Hospital, Inc

    lead OTHER

Principal Investigators

  • Cheryl Tansley, SLP · Gaylord Specialty Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-31
Completion
2018-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229639 on ClinicalTrials.gov